Specialist commentator comments
Comments on this technology were invited from clinical experts working in the field. The comments received are individual opinions and do not represent NICE's view.
One of the 3 specialist commentators had used Sternal Talon twice before, 1 had seen but not used it, and the other was not previously aware of it.
Two specialist commentators said that Sternal Talon was novel, with one commenting that it is the strongest, or most secure, sternal closure device available. One noted that a 'nitinol clip sternal closure device' is also available, but in their experience this is much weaker than Sternal Talon.
Another specialist commentator said that the design was interesting but not new because other similar devices have previously been proposed.
One of the specialist commentators felt that there was a potentially important role for Sternal Talon in secondary sternal closure, whereas the other 2 commentators could not identify any benefitting patient groups based on the current evidence.
One commentator noted that the potential benefits for using Sternal Talon for secondary closure arose from the fact that full dissection of the sternal halves is not needed, and it provides a broader surface area than wires. It may also be more secure in patients with a high body mass index and also reduce the risk of bleeding during recovery. The commentator referenced the DeLong (2014) case series as evidence that Sternal Talon can be used in patients with active mediastinitis. They noted, however, that Sternal Talon may be unsuitable for patients with little or thin subcutaneous tissue overlying the sternum, because it is more bulky than sternal wires. A second commentator echoed this concern that the cosmetic appearance of the Sternal Talon under the skin of the sternum would be unappealing.
One specialist commentator noted that the complication rates reported in the evidence (9 infections and 6 removals out of 233 patients) were higher than expected, and greater than those expected for sternal closure using wires. They were also concerned that Sternal Talon is only in load‑bearing contact with the lateral aspects of the sternum, whereas peristernal wires are in contact with all aspects of the sternum. Also, they felt that figure of 8 wires achieve better 3D‑fixation than Sternal Talon.
Two commentators noted a potential benefit of Sternal Talon in people who had postoperative bleeding. One speculated that re‑opening the sternum to treat this would be easier with Sternal Talon than with wires. Another stated that the most frequent cause of postoperative bleeding was because of wires puncturing the tissues under the sternum. They felt that the Sternal Talon may reduce this risk as it does not require the use of wires or needles, although noted that there are no data to substantiate this at present.
Two of the commentators noted a potential negative system impact of Sternal Talon, in that this technology is much more expensive than standard care and as yet does not have any convincing evidence to show patient benefit. No requirements for changes in facilities or infrastructure to adopt this technology were identified.
There may be some staff training needed in order to measure and select the correct size of device, how to place and secure it, and how to remove it in case of any complications.
Two specialists considered that use of Sternal Talon for primary sternal closure is unlikely to be cost saving because it is considerably more expensive than wire closure. One felt that cost savings might be made when using this for secondary closure.
All of the commentators felt that there was a need for more evidence for Sternal Talon. Specifically, one commentator noted that there is a need for large randomised trials of Sternal Talon compared with simple wires, figure of 8 wires, peristernal and trans‑sternal wires. In each of these cases, cost‑benefit analyses would be needed.
One commentator noted that standard wire closure already has a low complication and failure rate, particularly in primary sternal closure. Because of this, Sternal Talon may not be of benefit to a large patient population.